中药质量控制和新药研发的思路和方法

Recent Research Developments in the Modernization of Chinese Medicines

中药现代化的主要目标是中药的安全、有效和质量稳定、可控。作者在近年来的部分研究工作的基础上,本文对中药质量控制和以科学实证为基础的创新中药研究进行了探讨。中药质量控制的两个关键点就是分析技术的建立和化学对照品的运用。分析技术方面在继承形态组织学方法的基础上,发展DNA分子技术和色谱技术鉴别药材,建立各种现代色谱联用技术定量评价药材及其制剂的内在质量。加强高质量中药化学对照品的研制,提高质量控制水平;新药研究首先应针对传统中医药有治疗特色的疾病开展研究。可以在中医理论指导下对古方或验方进行二次开发,强调复方配伍,也可利用高通量筛选先导化合物。实证研究既注重分子、细胞、器官和整体动物药效学机理研究以及新制剂工艺的研究,还要强调随机、双盲和安慰剂对照的临床验证。本文还对当前中药质量控制和创新药物研发中存在的问题进行了讨论。

Safety, efficacy and quality control are the three key elements in the modernization and internationalization of traditional Chinese medicines （TCM）. In this paper, we summarize and discuss the issues on the quality control and the research and development of evidence-based TCM. Establishing analytical methodologies and expanding the application of chemical markers are crucial for the quality control of TCM. Apart from the well-known organonepic technique for TCM authentication, various advanced analytical methodologies including DNA sequencing, and hyphenated chromatographic methods have been used for the quantitative and qualitative analysis of the raw materials and products. As for new drug development, we focused on those TCMs that show promising effects on specific diseases or syndromes, including cardiovascular diseases, diabetes, irritable bowel syndrome, depression and menopausal syndrome. The strategies used for new drug development were either extensive evidence-based investigation of traditional formulas that are based on traditional Chinese medical theory, or lead compound discovery through high throughput screening. Both clinical trials of randomized, double-blind and placebo-controlled studies, and pharmacological and toxicological studies with molecular, celluar, organ and animal models were conducted. Factors which hinder the progress of quality control and new drug development are also addressed and discussed. In this review, 74 references published by the authors and collaborators over the past three years, were cited.